Access Hybritech p2PSA Reagent Recalled for Insufficient Blocking Reagent
Beckman Coulter is recalling Access Hybritech p2PSA diagnostic reagent kits with insufficient blocking reagent concentration. Three lot numbers affecting 987 kits were distributed in the US and internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device recall for a manufacturing quality defect in a diagnostic reagent. Medical devices are risk-of-harm products where defects in accuracy or performance could affect patient diagnosis. No illnesses or injuries are stated in the recall documentation.
Plain-English summary
Beckman Coulter, Inc. is recalling Access Hybritech p2PSA diagnostic reagent kits due to insufficient concentration of blocking reagent. Three lot numbers are affected: Lot #234320 (expiration 7/31/2023), Lot #234134 (expiration 6/30/2023), and Lot #234133 (expiration 6/30/2023), comprising 987 total kits.
The FDA classified this as a Class II medical device recall. The blocking reagent is a component of the diagnostic reagent system.
The kits were distributed to clinical laboratories and healthcare facilities in 19 US states: California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Massachusetts, Michigan, North Carolina, Nebraska, New Jersey, New York, Ohio, South Carolina, Tennessee, Texas, Utah, and Washington. International distribution covered 26 countries including Australia, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, India, Italy, Japan, Korea, Lithuania, Macao, Mexico, Portugal, Russia, Serbia, Singapore, Slovakia, Spain, Switzerland, Taiwan, and Vietnam. Government laboratories received kits, but military facilities did not.
Users with affected kits should verify lot numbers against their stock and contact Beckman Coulter for replacement, refund, or additional guidance.
The recalled product
- Product
- Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
- Manufacturer
- Beckman Coulter, Inc.
- Affected units
- 987
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 (8)
- Lot #234320
- exp. 7/31/2023
- UDI (01)15099590211325(17)230731(11)220731(10)234320
- Lot #234134
- exp. 6/30/2023
- UDI (01)15099590211325(17)230630(11)220630(10)234134
- and Lot #234133
- UDI (01)15099590204112(17)230630(11)220630(10)234133.
Distribution
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