Class II U.S. Food and Drug Administration

Diagnostica Stago, Inc. Brand Name: STA Liatest Free Protein S Product Name: STA recall: The potential of out-of-range results and an underestimation of the free

Recall published 8 months ago

The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.

The hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1491-2026
Published
March 11, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Diagnostica Stago, Inc.
Product type
Medical devices
Units affected
369
Distribution
Nationwide
Made in
United States
Lot / code info
Model/Catalog Number (REF): 00516; UDI: (1) (01)03607450005165(11)241001(17)260131(10)271971(241)00516, (2) (01)03607450005165(11)250221(17)260531(10)272859(241)00516, (3) (01)03607450005165(11)250306(17)260630(10)273018(241)00516, (4) (01)03607450005165(11)250430(17)260831(10)273426(241)00516; Lot numbers: (1) 271 971, (2) 272 859, (3) 273 018, (4) 273 426; Lot Code: 271 971 (01)03607450005165(11)241001(17)260131(10)271971(241)00516
UPC codes
03607450005165

Products covered by this recall

Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Compact¿ for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. Component: Not Applicable

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.

  • 03607450005165

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 271 971

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 Device

Diagnostica Stago, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

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: Diagnostica Stago, Inc. — 5 Century Dr, Parsippany, NJ, 07054-4607

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 Diagnostica Stago, Inc. medical devices recalled?

The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values. The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 03607450005165; lot code 271 971. 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 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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