Class II U.S. Food and Drug Administration

Abbott Laboratories Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer recall: Software issue for hq analyzer results in system not visibly applying

Recall published 11 months ago

Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.

The hazard: Device malfunction

The notice describes a specific failure mode. That detail is what a clinician needs, because the right action differs sharply between a monitor, an implant and a test kit.

What the notice says: Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.

Why it matters: The device may not perform as intended — a mechanical failure, a software defect, an inaccurate reading, or an alarm that does not sound. For a device someone depends on, the consequence of the failure is usually worse than the failure itself.

Symptoms and when to call a doctor

If the device supports a vital function, do not disable or remove it on your own judgement. Contact the clinician who prescribed or fitted it, and use the back-up arrangement they gave you. Go to an emergency department if the symptoms the device is meant to manage are getting worse, or if an implanted device gives an unexpected alarm or shock.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0489-2026
Published
November 19, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Abbott Laboratories
Product type
Medical devices
Units affected
833
Distribution
Nationwide
Made in
United States
Lot / code info
SN UDI HQ00480 (01)380740138851(21)HQ00480 HQ01231 (01)380740138851(21)HQ01231 HQ01232 (01)380740138851(21)HQ01232 HQ01233 (01)380740138851(21)HQ01233 HQ01236 (01)380740138851(21)HQ01236 HQ01237 (01)380740138851(21)HQ01237 HQ01238 (01)380740138851(21)HQ01238 HQ01239 (01)380740138851(21)HQ01239 HQ01240 (01)380740138851(21)HQ01240 HQ01241 (01)380740138851(21)HQ01241 HQ01244 (01)380740138851(21)HQ01244 HQ01246 (01)380740138851(21)HQ01246 HQ01247 (01)380740138851(21)HQ01247 HQ01248 (01)380740138851(21)HQ01248 HQ01249 (01)380740138851(21)HQ01249 HQ01250 (01)380740138851(21)HQ01250 HQ01252 (01)380740138851(21)HQ01252 HQ01253 (01)380740138851(21)HQ01253 HQ01256 (01)380740138851(21)HQ01256 HQ01257 (01)380740138851(21)HQ01257 HQ01263 (01)380740138851(21)HQ01263 HQ01265 (01)380740138851(21)HQ01265 OUS: HQ00117 (01)380740138851(21)HQ00117 HQ00119 (01)380740138851(21)HQ00119 HQ00120 (01)380740138851(21)HQ00120 HQ00126 (01)380740138851(21)HQ00126 HQ00127 (01)380740138851(21)HQ00127 HQ00128 (01)380740138851(21)HQ00128 HQ00132 (01)380740138851(21)HQ00132 HQ00136 (01)380740138851(21)HQ00136 HQ00139 (01)380740138851(21)HQ00139 HQ00140 (01)380740138851(21)HQ00140 HQ00141 (01)380740138851(21)HQ00141 HQ00144 (01)380740138851(21)HQ00144 HQ00145 (01)380740138851(21)HQ00145 HQ00148 (01)380740138851(21)HQ00148 HQ00149 (01)380740138851(21)HQ00149 HQ00152 (01)380740138851(21)HQ00152 HQ00154 (01)380740138851(21)HQ00154 HQ00157 (01)380740138851(21)HQ00157 HQ00162 (01)380740138851(21)HQ00162 HQ00164 (01)380740138851(21)HQ00164 HQ00166 (01)380740138851(21)HQ00166 HQ00169 (01)380740138851(21)HQ00169 HQ00171 (01)380740138851(21)HQ00171 HQ00172 (01)380740138851(21)HQ00172 HQ00173 (01)380740138851(21)HQ00173 HQ00174 (01)380740138851(21)HQ00174 HQ00175 (01)380740138851(21)HQ00175 HQ00183 (01)380740138851(21)HQ00183 HQ00184 (01)380740138851(21)HQ00184 HQ00185 (01)380740138851(21)HQ00185 HQ00187 (01)380740138851(21)HQ00187 HQ00191 (01)380740138851(21)HQ00191 HQ00192 (01)380740138851(21)HQ00192 HQ00194 (01)380740138851(21)HQ00194 HQ00196 (01)380740138851(21)HQ00196 HQ00197 (01)380740138851(21)HQ00197 HQ00198 (01)380740138851(21)HQ00198 HQ00201 (01)380740138851(21)HQ00201 HQ00203 (01)380740138851(21)HQ00203 HQ00204 (01)380740138851(21)HQ00204 HQ00208 (01)380740138851(21)HQ00208 HQ00209 (01)380740138851(21)HQ00209 HQ00210 (01)380740138851(21)HQ00210 HQ00215 (01)380740138851(21)HQ00215 HQ00217 (01)380740138851(21)HQ00217 HQ00218 (01)380740138851(21)HQ00218 HQ00222 (01)380740138851(21)HQ00222 HQ00223 (01)380740138851(21)HQ00223 HQ00230 (01)380740138851(21)HQ00230 HQ00240 (01)380740138851(21)HQ00240 HQ00242 (01)380740138851(21)HQ00242 HQ00243 (01)380740138851(21)HQ00243 HQ00244 (01)380740138851(21)HQ00244 HQ00245 (01)380740138851(21)HQ00245 HQ00246 (01)380740138851(21)HQ00246 HQ00248 (01)380740138851(21)HQ00248 HQ00249 (01)380740138851(21)HQ00249 HQ00250 (01)380740138851(21)HQ00250 HQ00252 (01)380740138851(21)HQ00252 HQ00254 (01)380740138851(21)HQ00254 HQ00255 (01)380740138851(21)HQ00255 HQ00258 (01)380740138851(21)HQ00258 HQ00259 (01)380740138851(21)HQ00259 HQ00261 (01)380740138851(21)HQ00261 HQ00264 (01)380740138851(21)HQ00264 HQ00265 (01)380740138851(21)HQ00265 HQ00266 (01)380740138851(21)HQ00266 HQ00268 (01)380740138851(21)HQ00268 HQ00269 (01)380740138851(21)HQ00269 HQ00270 (01)380740138851(21)HQ00270 HQ00271 (01)380740138851(21)HQ00271 HQ00273 (01)380740138851(21)HQ00273 HQ00274 (01)380740138851(21)HQ00274 HQ00276 (01)380740138851(21)HQ00276 HQ00277 (01)380740138851(21)HQ00277 HQ00278 (01)380740138851(21)HQ00278 HQ00279 (01)380740138851(21)HQ00279 HQ00281 (01)380740138851(21)HQ00281 HQ00282 (01)380740138851(21)HQ00282 HQ00283 (01)380740138851(21)HQ00283 HQ00286 (01)380740138851(21)HQ00286 HQ00287 (01)380740138851(21)HQ00287 HQ00289 (01)380740138851(21)HQ00289 HQ00291 (01)380740138851(21)HQ00291 HQ00293 (01)380740138851(21)HQ00293 HQ00295 (01)380740138851(21)HQ00295 HQ00296 (01)380740138851(21)HQ00296 HQ00299 (01)380740138851(21)HQ00299 HQ00302 (01)380740138851(21…
UPC codes
380740138851

Products covered by this recall

Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No

Check your product

The notice names 2 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 380740138851

Model or item number

On the rating label, the box or the instruction sheet.

  • 09P68-01 Software Version

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Malfunction

Abbott Laboratories — The notice describes a specific failure mode. That detail is what a clinician needs, because the right action differs sharply between a monitor, an implant and a test kit.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.
  2. Report device problems to the FDA through MedWatch — that database is where this recall came from.
  3. If the device is implanted, or you depend on it daily, speak to your clinician before changing anything about how you use it.
  4. Check whether the remedy is a software update, and if so confirm afterwards in the device menu that the version actually changed.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Abbott Laboratories — 4551 Great America Pkwy, Santa Clara, CA, 95054-1208

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Abbott Laboratories medical devices recalled?

Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results. Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 380740138851; model number 09P68-01 Software Version. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers listed on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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