Recall Z-2170-2011 ยท LCP Assay, Glycosylated Hemoglobin
Beckman Coulter Inc.
Beckman Coulter HbA1c APT (Hemoglobin A1c, Whole Blood Application), Part Number: OSR61177, Lot Numbers: 9390 & 9472 Immuno-inhibition test for the quantitative determination of HbA1c (Hemoglobin A1c), in human whole blood, on the Beckman Coulter AU680 with whole blood automated pretreatment (APT) capability only. For in vitro diagnostic use only. The absolute HbA1c and Total Hemoglobin (THb) valu
| Date | May 10, 2011 (initiated Mar 1, 2011) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Pending |
| Action | 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. I |
| Quantity | 373 kits |
| Distribution | Worldwide Distribution - USA (Nationwide) Austria, Croatia, France, Germany, Korea, Philippines, Russian Federation, Thailand, Venezuela, and Vietnam. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031380 | OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) Olympus America, Inc., Nov 14, 2003 |