—#90258

Product

Access Immunoassay Systems PROGESTERONE, Part Number: 33550

FDA product code: JLS — Radioimmunoassay, Progesterone
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K955769
Affected lot / code info: Lot Numbers: 913013 and 914457

Why it was recalled

The recall was initiated by Beckman Coulter after the firm confirmed customer reports that the affected lot of Access Cortisol reagent (REF 33600) identified above may produce suppressed patient results. Beckman Coulter also confirmed customer reports that the two lots of Access Progesterone reagent (REF 33550) identified above may produce suppressed patient results and an increased incidence of I

Root cause (FDA determination)

Other

Action the firm took

Two (2) Product Corrective Action (PCA) letters with attached Customer Response form were sent on the week of February 15, 2010 to the affected customers. The letters provide the customers with an explanation of the problem identified and instruct the customers to discontinue use of Access Progesterone and Access Cortisol Reagents, lot numbers referenced. For product replacements consignees were instructed : (1) In the United States, please contact Customer Service at 1-800-526-3821; (2) In Canada, please contact Customer Service at 1-800-463-7828; (3) Outside of the United States and Canada, contact your local Beckman Coulter Representative. If consignees need assistance or have any questions regarding this notification, they were instructed to contact Technical Support at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact your local Beckman Coulter Representative.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 200 S Kraemer Blvd, Brea, California 92821-6208

Distribution

Distribution pattern: United States & Canada

Timeline

Recall initiated: 2010-02-17
Posted by FDA: 2010-09-29
Terminated: 2012-04-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90258. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.