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U.S. Department of Health and Human Services

Class 2 Device Recall Access

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 Class 2 Device Recall Accesssee related information
Date Initiated by FirmMay 17, 2023
Date PostedJune 30, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2043-2023
Recall Event ID 92369
PMA NumberP090026 
Product Classification P2psa - Product Code OYA
ProductAccess Hybritech p2PSA reagent, REF B03704 and REF A49752.
Code Information 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.
FEI Number 2122870
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
1000 Lake Hazeltine Dr
Chaska MN 55318-1037
For Additional Information ContactAdam Viitala
714-993-5321
Manufacturer Reason
for Recall		Reagent lot numbers include an insufficient concentration of blocking reagent.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe 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 Commerce987 kits
DistributionDistribution 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = OYA
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