Beckman Coulter IgA Diagnostic Reagent Recalled for Lipemic Test Interference
Beckman Coulter is recalling approximately 12,850 units of IgA diagnostic reagent due to performance failures when testing lipemic blood samples, which could lead to inaccurate test results.
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 a Class II FDA recall of a diagnostic reagent that failed to meet performance specifications when testing lipemic samples. The failure in diagnostic test performance that could lead to inaccurate results constitutes a risk-of-harm scenario, justifying a High severity rating.
Plain-English summary
Beckman Coulter Inc. is recalling approximately 12,850 units of its IgA (immunoglobulin A) diagnostic reagent, REF: OSR61171. The reagent is used in clinical laboratories to measure immunoglobulin A levels in patient blood samples.
The product failed to meet the performance specifications outlined in its instructions for use when testing lipemic samples. Lipemia occurs when blood samples contain elevated levels of lipids or fats. In these cases, lipemic interference can cause the test to produce inaccurate results, potentially affecting patient diagnoses.
The affected product has been distributed to clinical facilities in 40 U.S. states and more than 30 countries. All affected units are identified by the UDI (01)15099590011574.
Laboratories that may have received this product should identify affected units and consult with Beckman Coulter for guidance on remedial actions, including possible patient sample re-testing. Healthcare providers should not use affected batches for patient testing.
The recalled product
- Product
- Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
- Manufacturer
- Beckman Coulter Inc.
- Hazard
- test-inaccuracy
- lipemic-interference
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 (1)
- All Lots/UDI-(01)15099590011574
Distribution
Distributed in 42 states:
- AL
- AR
- AZ
- CA
- CO
- CT
- DC
- DE
- FL
- GA
- IA
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- MI
- MN
- MO
- MS
- NC
- ND
- NE
- NJ
- NM
- NY
- OH
- OK
- OR
- PA
- RI
- SC
- SD
- TN
- TX
- UT
- VA
- WA
- WI
- WV
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