Beckman Coulter HbA1c APT (Hemoglobin A1c, Whole Blood Application), Part Number: OSR61177, Lot Numbers: 9390 & 9472 Imm
FDA device recall Z-2170-2011 · posted 2011-05-10 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- The recall was initiated because Beckman Coulter has identified a problem with two lots of HbA1c APT reagent OSR61177. When HbA1c APT reagent lots 9390 and 9472 are calibrated with HbA1c calibrator ODR3032, elevated recovery may be observed for patient samples. Falsely elevated HbA1c values may be interpreted as increased risk for diabetes or poorly controlled diabetes. Consequent medical acti
- Action taken
- Beckman Coulter initiated the recall communication with a Product Corrective Action (PCA) letter with attached recall response form on March 1, 2011 to the affected customers. The letter explained the problem and identified the action to be taken. The PCA also instructed the consignees to: (1) Please discontinue the use of lots 9390 and 9472 and discard according to your local procedures. (2) Please contact your local Beckman Coulter support Organization for replacement reagent. (3) You may need to re-evaluate samples for HbA1c which were tested with either of the listed lots of reagent. In addition, customers were instructed to: (1) share the information with their laboratory staff and retain this notification as part of their Quality System documentation. If any of the affected product was forwarded to another laboratory, a copy of the letter should be provided to them. (2) complete and return the enclosed response form within 10 days so that the firm was assured the customer received the important communication. For any questions regarding this notice, customers were instructed to contact Customer Technical Support at 1-800-854-3633 in the U.S.A and at 00353656831111 in Europe.
- Root cause
- Pending
- Status
- Terminated
- Product code
- LCP
- Quantity affected
- 373 kits
- Distribution
- Worldwide Distribution - USA (Nationwide) Austria, Croatia, France, Germany, Korea, Philippines, Russian Federation, Thailand, Venezuela, and Vietnam.
- Date initiated
- 2011-03-01
- Date posted
- 2011-05-10
- Date terminated
- 2012-06-28
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) (K031380) | Olympus America, Inc. | 2003-11-14 |