Recall Z-1932-2011
Bio-Rad Laboratories Inc · initiated December 1, 2009
Product
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 liquid chromatography (HPLC). The Bio-Rad VARIANT II. TURBO Hemoglobin Alc Program is intended for Professional Use Only--For In Vitro Diagnostic Use. Reagent Kit Information: The VARIANT II TURBO Hemoglobin A1c program utilizes principles of ionexchange high performance liquid chromatography (HPLC). The VARIANT II Hemoglobin A1c Program is based on chromatographic separation of HbAlc on a cation exchange cartridge. System Overview: The VARIANT II TURBO Hemoglobin testing System provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin Alc in EDTA human whole blood. Technology Overview: The V ARIANT II TURBO Hemoglobin Testing is a fully automated, high-throughput hemoglobin analyzer. It consists of two modules- the VARIANT II Chromatographic Station (VCS) and the VARIANT II Sampling Station (VSS). In addition, a personal computer is used to control the VARIANT II TURBO System using Clinical Data Management (CDM) software. CDM is a dedicated software package of instrument control, data control, results analysis, calibration, quality control and service software.
Codes / lots: Catalog No. 270-2415: LOTS: Lot 70291500 Exp. June 30, 2010; Lot 70292239 Exp. June 30, 2010; and Lot 70292240 Exp. June 30, 2010. Catalog No. 270-2417: LOTS: Lot 70291520 Exp. Dec. 2, 2009; Lot 70292241 Exp.Dec.2, 2009; Lot 70291520R Exp. Jan. 31, 2010; Lot 70292242 Exp.Jan.31, 2010; and Lot 70292318 Exp. Jan. 31, 2010
Reason for recall
Some customers have reported the occurrence of some ramping baselines on the chromatograms. The ramping baseline can affect hemoglobin test results.
FDA-determined cause: Software change control
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.
Details
- Recall number
- Z-1932-2011
- Initiated
- December 1, 2009
- Posted by FDA
- April 11, 2011
- Terminated
- August 30, 2011
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- 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.
- Recalling firm
- Bio-Rad Laboratories Inc, Hercules, CA