Recall Z-1537-2014— Bio-Rad Laboratories, Inc.
Class II · Terminated
Class II FDA medical device recall by Bio-Rad Laboratories, Inc., initiated 2014-04-08, terminated 2014-05-30. It names one FDA 510(k) clearance: K991127. Product: Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin.. Reason: There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used..
- Recalling firm
- Bio-Rad Laboratories, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-04-08
- Terminated
- 2014-05-30
- Firm location
- Hercules, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin.
Reason for recall
There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used.
Data sourced from openFDA. This site is unofficial and independent of the FDA.