Z-2043-2023Class II

Access Hybritech p2PSA reagent, REF B03704 and REF A49752

Name: Z-2043-2023 Access Hybritech p2PSA reagent, REF B03704 and REF A49752
Creator: Beckman Coulter, Inc.
Published: 2023-05-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-05-17 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of Access Hybritech p2PSA reagent, REF B03704 and REF A49752 on 2023-05-17. FDA classified it as Class II and gives the reason as "Reagent lot numbers include an insufficient concentration of blocking reagent". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2043-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-17
Posted: 2023-06-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Hybritech p2PSA reagent, REF B03704 and REF A49752.
Product code: OYA P2psa
Reason for recall: Reagent lot numbers include an insufficient concentration of blocking reagent.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued letters to U.S. consignees dated 5/15/2023 via first class mail and email on 5/17/2023. The letter described the issue, impact, and the action to be taken. The consignee was instructed to discontinue using the reagent lots that were listed and discard all remaining reagent packs from the lots. The letter was to be shared with the consignee laboratory and/or medical director regarding the need to review previous patient test results. The Beckman Coulter representative was to be contacted for replacement product requests. If the product was forwarded to another laboratory, the consignee is to provide them a copy of the letter. The consignee is requested to respond within 10 days of receipt of the letter either electronically or manually by completing the enclosed Response Form. The letter for the OUS consignees was dated 5/16/2023 and was similar to the letter for the U.S. consignees.
Quantity in commerce: 987 kits
Distribution: Distribution was made to CA, CO, CT, FL, GA, IL, IN, MA, MI, NC, NE, NJ, NY, OH, SC, TN, TX, UT, and WA. There was government distribution but no military distribution. Foreign distribution was made to 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.
Product codes and lots: 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, exp. 6/30/2023, UDI (01)15099590204112(17)230630(11)220630(10)234133.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2043-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2043-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-05	2023-06-29

Product code OYA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)