Lp(a) Calibrator, Cat No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box ,Waco Chemicals USA, Inc., 1600 Bellwood Road Richmond, VA 23237, Manufactured by: Wako Pure Chemical Industries, Ltd. Osaka Japan
FDA Recall Z-1409-06 · Posted 2006-08-25
Recalling FirmWako Chemicals, USA Inc
Recall StatusTerminated
Product CodeMMY
Date Initiated2006-07-06
Date Terminated2006-09-14
Product Quantity136 kits
Reason for Recall
Unexpected low cholesterol results-The Cholesterol calibrator (Lp(a)) component of the in vitro diagnostic kit for cholesterol testing, has provided patient results lower than the correct value.
Firm Action
The recalling firm notified consignees by phone and e-mail with an attached letter dated 07/06/06. The notification, flagged as ''Important Device Recall'' advised consignees to stop using the recalled product and that Lp(a) results showed a decrease in value of approximately 10% when the identified lots are used. Consignees were requested to return the enclosed response form for replacement product.
Root Cause
Process control
Distribution Pattern
The product was sold to one distributor and direct medical accounts Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.