Bio Rad brand VARIANT II TURBO Hemoglobin Alc Program, 1600 and 2000 tests Cartridge Sets. Catalog Numbers: 270-2417 and

FDA device recall Z-1932-2011 · posted 2011-04-11 · Terminated

Recall details

Recalling firm

Bio-Rad Laboratories Inc

Reason for recall

Some customers have reported the occurrence of some ramping baselines on the chromatograms. The ramping baseline can affect hemoglobin test results.

Action taken

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 510-741-3954 or pdf to CSD Recall Coordinator (excluding USSD). For questions regarding this recall call 510-724-7000.

Root cause

Software change control

Status

Terminated

Product code

LCP

Quantity affected

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, Br

Date initiated

2009-12-01

Date posted

2011-04-11

Date terminated

2011-08-30

Location

Hercules, CA