Recall Z-0977-2013
Mindray DS USA, Inc. d.b.a. Mindray North America · initiated November 28, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BS-200 Chemistry Analyzer Designed for clinical laboratory use.
Codes / lots: Part number BA20E-PA00003; Serial Numbers: WN-28103978F, WN-28103976F, and WN-28103977F.
Reason for recall
An issue has been identified with the BS-200 where clinical chemistry results may be inaccurate.
FDA-determined cause: Device Design
Action taken
Mindray North America /Mindray DS USA Inc. sent Urgent Product Corrective Action letters via certified mail, return receipt requested, signature required on 11/28/2012. The letters identified the affected product as well as the issue, effect on patients, and the corrective action. Customers are to remove the analyzer from service until the affected pump has been replaced. Also, customers are to contact Mindray Customer Service Representative Tony Li at 1-800-288-2121 x2112 for technical assistance, and to arrange for replacement pumps at no charge.
Details
- Recall number
- Z-0977-2013
- Initiated
- November 28, 2012
- Posted by FDA
- March 22, 2013
- Terminated
- June 12, 2013
- Product code
- CFR – Hexokinase, Glucose
- Quantity
- 3 units
- Distribution
- Distributed in the states of NC and TX.
- Recalling firm
- Mindray DS USA, Inc. d.b.a. Mindray North America, Mahwah, NJ