The Recall Desk
HighFDA (Devices)·Z-1628-2023·Announced 2023-05-31

VITROS Chemistry HbA1c Reagent Kit recalled due to inaccurate test results

Ortho-Clinical Diagnostics is recalling VITROS Chemistry HbA1c Reagent Kits due to potential for false-positive and false-negative results, which may lead to misdiagnosis.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a diagnostic device with potential for both false-positive and false-negative results that could lead to patient misdiagnosis. No actual illnesses or injuries have been reported; the hazard is the theoretical risk of inaccurate results affecting diabetes management.

Plain-English summary

Ortho-Clinical Diagnostics, Inc. is recalling VITROS Chemistry Products HbA1c Reagent Kits due to the potential for both false-positive and false-negative test results. This in vitro diagnostic kit is used to quantify percent and mmol/mol of glycated hemoglobin A1c in human whole blood samples.

The defect may cause unexpected and inaccurate results, potentially leading to misdiagnosis. The recall affects 23,751 units distributed nationwide and internationally to Australia, Belgium, Brazil, Bermuda, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, the Netherlands, and the United Kingdom.

Affected lots and expiration dates include: 29-9396 (2023-SEP-02), 29-9466 (2023-SEP-02), 30-9647 (2023-NOV-25), 30-9803 (2023-NOV-25), 31-9648 (2024-JAN-24), 32-9925 (2024-APR-14), 33-1097 (2024-JUL-18), 33-1105 (2024-JUL-18), 33-1228 (2024-JUL-18), and 34-1345 (2024-OCT-17). All currently distributed lots and all future lots are considered affected until additional notification is received from Ortho-Clinical Diagnostics.

Healthcare facilities using this product should discontinue use of affected lots. Patients whose test results were obtained using affected lots may need to consult their healthcare provider about retest options.

The recalled product

Product
VITROS Chemistry Products HbA1c Reagent Kit- IVD for the quantitative determination of percent glycated hemoglobin A1c (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in human whole blood. Product Code: 6842905
Manufacturer
Ortho-Clinical Diagnostics, Inc.
Category
Medical Device — In Vitro Diagnostic
Hazard
  • test-inaccuracy
  • misdiagnosis-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • UDI-DI: 10758750030729 Lot Number/Expiry: 29-9396 2023-SEP-02
  • 29-9466 2023-SEP-02
  • 30-9647 2023-NOV-25
  • 30-9803 2023-NOV-25
  • 31-9648 2024-JAN-24
  • 32-9925 2024-APR-14
  • 33-1097 2024-JUL-18
  • 33-1105 2024-JUL-18
  • 33-1228 2024-JUL-18

Distribution

Distributed nationwide across the United States.

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