RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use.
- Company
- Perkinelmer Las Inc
- Recall Initiated
- June 29, 2004
- Posted
- July 23, 2004
- Terminated
- October 29, 2008
- Recall Number
- Z-1158-04
- Quantity
- 146
- Firm Location
- Norton, OH
Reason for Recall
Hemoglobin Test Kit Catholyte Solution generating false positive results, were distributed.
Distribution
The recalled kits were distributed to customers in the following locations: FL, OK, GA, MD, AZ, KY, NY, PR, OR, NJ, WA, MI, KS, AR, IN, TX, MN, CA, VA, NC, DE, UT, WI, SC, OH, MT, KS, CO & PR.
Lot / Code Info
Catholyte Solution Batch Lot #235867, included in kits labeled with Kit Lot Numbers: 234172, 234177, 234182, 234190, 234195, 234200, 234205, 234222, 234231, 234240, 234247, 234252, 234257, 234262, 234267, 234272, 234277, 238917, 238920 & 238923.
Root Cause
Other
Action Taken
The firm contacted their customers via telephone and notified them of the recall on 6/29/2004. A follow-up recall letter was also issued on 6/29/2004. The letter requests that the customer either destroy the product or return it to the firm for replacement. Also attached for completion and to be faxed back to the recalling firm, is a questionaire which documents the customer''s receipt of the product and recall letter; any reports of illness or injury in connection with the use of the product; and the customer''s proposed disposition of the kits i.e. return or destruction. Additional follow-up with all non-responding customers will take place in 2 weeks.