Wako Chemicals, USA Inc 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Wako Chemicals, USA Inc
Lot Codes / Batch Numbers
Lots Numbers-EK560 EXP 7/31/06 and EH213 EXP 9/30/06
Products Sold
Lots Numbers-EK560 EXP 7/31/06 and EH213 EXP 9/30/06
Wako Chemicals, USA Inc is recalling Lp(a) Calibrator, Cat No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box ,Waco Chemi due to Unexpected low cholesterol results-The Cholesterol calibrator (Lp(a)) component of the in vitro diagnostic kit for cholesterol testing, has provided p. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026