Recall Z-0110-2013
Beckman Coulter Inc. · initiated December 15, 2011
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate,Magnesium, Total Protein, Triglycerides, and Uric Acid.
Codes / lots: Lot M002642
Reason for recall
The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron Systems Multi Calibrator Diskettes (REF 442600, lot M002642G) may actually be Thyroxine (T4) Reagent Calibrator Diskettes.
FDA-determined cause: Labeling mix-ups
Action taken
Beckman Coulter sent an Urgent Product Correction letter dated December 15, 2011, withan attached Fax Back Response Form to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. If customers are currently using Multi Calibrator lot M002642, then they were instructed to verified diskette and discard all Multi Calibrator diskettes lot M002642 and M002642G without a dark green dot. Customers were instructed to complete and return the enclosed Response Form within 10 days. Customers were instructed to contact Beckman Coulter Support Center at http:www.beckmancoulter.com/customersupport/support/ or call (800) 854-3633 in the US and Canada. Outside of the US or Canada, customers were instructed to contact their local Beckman Coulter Representatives. For questions regarding this recall call 714-961-4483.
Details
- Recall number
- Z-0110-2013
- Initiated
- December 15, 2011
- Posted by FDA
- October 22, 2012
- Terminated
- December 28, 2012
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Quantity
- 5746 units total (2729 units in US)
- Distribution
- Worldwide distribution: USA (Nationwide) and Internationally to: Afghanistan Angola Australia Bangladesh Belgium Bhutan Brazil Brunei Darussalam Bulgaria Canada China Colombia Costa Rica Cote d'Ivoire Czech Republic Denmark Ecuador Egypt El Salvador Eritrea Ethiopia Finland France French Polynesia Germany Ghana Greece Guatemala Hong Kong India Indonesia Ireland Israel Italy Japan Jordan Kenya…
- Recalling firm
- Beckman Coulter Inc., Brea, CA