Recall Z-1299-2014
Bio-Rad Laboratories, Inc. · initiated February 27, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by: Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Drive Hercules, CA 94545 The D-10 Hemoglobin Testing System is a single module designed for hemoglobin analysis in mid-volume laboratories. The D-10 is a fully integrated system for sample dilution, processing and analysis of hemoglobin, designed for use with specific Bio-Rad reagent kits. The D-10 incorporates the use of a dedicated software system for instrument control, data collection and analysis.
Codes / lots: Model number: 220-0220
Reason for recall
On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample.
FDA-determined cause: Nonconforming Material/Component
Action taken
Bio-Rad Laboratories, Inc. sent an Urgent Medical Device correction letter dated February 27, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. A Customer medical Device Correction Response Form must be collected from each customer to ensure that they have received this communication. Forms should be faxed to the Bio-Rad CSD Regulatory Affairs Department at 510-741-3954 along with the completed Subsidiary Medical Device Correction Response Form. For questions regarding this recall call 570-741-6114.
Details
- Recall number
- Z-1299-2014
- Initiated
- February 27, 2014
- Posted by FDA
- March 27, 2014
- Terminated
- June 4, 2014
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Quantity
- 483 instruments in US. OUS to be determined.
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Canada, Japan, China, India, SriLanka, Argentina, Paraguay, Uruguay, Chile, Peru ,Bolivia ,Mexico ,Panama, ,Costa Rica ,Ecuador, Venezuela, Colombia, Brazil, Jamaica, Austria, Switzerland, France, Germany, Greece, Portugal, Spain, Italy, UK, Belgium, Sweden Norway, Finland ,Israel/Palestine, Tunisia, Algeria, Egypt, ,Morocco…
- Recalling firm
- Bio-Rad Laboratories, Inc., Hercules, CA