Class II U.S. Food and Drug Administration

Microgenics Corporation Thermo scientific MAS Omni Cardio recall: The firm received complaints from customers reporting vial-to-vial

Recall published 12 months ago

The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.

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 firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.

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-0415-2026
Published
November 5, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Microgenics Corporation
Product type
Medical devices
Units affected
4462
Distribution
Nationwide
Made in
United States
Lot / code info
OCRD-UL: UDI/DI 00884883011946, Lot Number OCRD2704U, Exp 2027-04-30; OCRD-L: UDI/DI 00884883011953, Lot Number OCRD2704L, Exp 2027-04-30; OCRD-101: UDI/DI 00884883011960, Lot Number OCRD27041, Exp 2027-04-30; OCRD-202: UDI/DI 00884883011977, Lot Number OCRD27042, Exp 2027-04-30; OCRD-303: UDI/DI 00884883011984, Lot Number OCRD27043, Exp 2027-04-30; OCRD-SP: UDI/DI 00884883011991, Lot Number OCRD2704S, Exp 2027-04-30; OCRD-MP: UDI/DI 00884883012004, Lot Number OCRD2704M, Exp 2027-04-30.
UPC codes
00884883011946, 00884883011953, 00884883011960, 00884883011977, 00884883011984, 00884883011991, 00884883012004

Products covered by this recall

Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagnostic external control

Check your product

The notice names 25 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.

  • 00884883011946
  • 00884883011953
  • 00884883011960
  • 00884883011977
  • 00884883011984
  • 00884883011991
  • 00884883012004

Lot or batch code

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

  • OCRD2704U
  • Exp 2027-04-30
  • OCRD2704L
  • OCRD27041
  • OCRD27042
  • OCRD27043
  • OCRD2704S
  • OCRD2704M
  • Exp 2027-04-30. — 4462

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 2027-04-30
  • 2027-04-30. — 4462

Model or item number

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

  • OCRD-L
  • OCRD-101
  • OCRD-202
  • OCRD-303
  • OCRD-SP
  • OCRD

Package size

Match the net weight or the piece count on the front of the pack.

  • 2704 L

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

Microgenics Corporation — 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. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  3. Ask the supplier or clinic that provided it what the remedy is in your case.
  4. If you are a facility, quarantine affected stock and log the correction.

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: Microgenics Corporation — 46500 Kato Rd, Fremont, CA, 94538-7310

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 Microgenics Corporation medical devices recalled?

The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays. The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00884883011946, 00884883011953, 00884883011960; lot code OCRD2704U, Exp 2027-04-30, OCRD2704L; best-by date 2027-04-30 or 2027-04-30. — 4462; model number OCRD-L, OCRD-101, OCRD-202. 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.

Related recalls