Recall Z-0029-2014 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
OPTI Medical Systems, Inc
Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma.
| Date | Oct 18, 2013 (initiated Aug 9, 2013) |
| Status | Terminated |
| Reason | OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance of one or more parameters as the product ages. Also a Customer complaint from a distributor reported that a customer was getting QC failures. |
| Root cause | Error in labeling |
| Action | The firm, OPTIMedical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 9, 2013 via email and fax to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the product; return any unused product to OPTI Medical System; distributors outside the U.S. may destroy unused product and certify the instructions on the enclosed Recall Response Card; contact your distributor or OPTI Medical System Technical Support at 1-800-490-6784 or technicalsupport@optimedical.com to obtain authorization number and |
| Quantity | 361 boxes of 25 cassettes each |
| Distribution | Worldwide distribution: US (nationwide) including states of: CA, MA, MN, and VA; and countries of: China, Guatemala, India, Iraq, South Korea, and Untied Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052027 | OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 Osmetech, Inc., Sep 29, 2005 |