Recall Z-1932-2011 ยท LCP Assay, Glycosylated Hemoglobin
Bio-Rad Laboratories Inc
Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge Sets. Catalog Numbers: 270-2417 and 270-2415; Distributed and Manufactured by: Bio-Rad Laboratories, Inc. Hercules, CA The Intended Use is as follows: The Bior-Rad II TURBO Hemoglobin A1c Program is intended for the percent determination of hemoglobin Alc in human whole blood using ion-exchange high-performance li
| Date | Apr 11, 2011 (initiated Dec 1, 2009) |
| Status | Terminated |
| Reason | Some customers have reported the occurrence of some ramping baselines on the chromatograms. The ramping baseline can affect hemoglobin test results. |
| Root cause | Software change control |
| Action | Bio Rad Laboratories, Inc. sent an Urgent Medical Device Correction letter dated December 1, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediatey examine their records to identify all customers who received one of the affected lots. Collect a Customer Medical Device Correction Response Form from every customer. Once forms were received from all applicable customers, complete the following Medical Device Correction Response Form and fax it to Bio-Rad CSD Regulatory Affairs at 510- |
| Quantity | 1099 |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia, New Zealand, Taiwan, Singapore, India, China, S. Korea, Hong Kong, France, Sweden, United Kingdom, Italy, Hungary, Germany, Brazil, Mexico and Colombia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.