—#93769

Product

IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part Number: DSL-6600 usage: The DSL6600 IGFBP-3 immunoradiometric assay (IRMA) kit provides materials for the quantitative measurement of IGFBP-3 in serum. This assay is intended for in vitro diagnostic use.

FDA product code: CFL — Radioimmunoassay, Human Growth Hormone
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K950228
Affected lot / code info: Lot Numbers: 991017, 991225, 991384, 991694, 991938, 992171, 992372, 992703, 100115A, 100205A, 100205B, 100226A, 100319A, 100409A, 100409B, 100430A and 100521A

Why it was recalled

The recall was initiated after Beckman Coulter confirmed customer reports that IGFBP-3 measurements using IGFBP-3 IRMA kit (REF DSL-6600) lots identified above may result in IGFBP-3 levels that are not in agreement with simultaneously measured levels of IGF-1. The investigation confirmed that above mentioned lots of IGFBP-3 kit provide results elevated by 84% on average. Erroneously elevated IGF

Root cause (FDA determination)

Pending

Action the firm took

The recall communication was initiated with a Product Corrective Action (PCA) letter that was sent on August 09, 2010 to all customers who received the IGFBP-3 IRMA kits, lot numbers referenced. The letter will provide the customers with an explanation of the problem identified and an action to be taken. Customers were instructed to: (1) Discontinue using all lots identified above and discard in accordance with local regulations. (2) To continue testing for IGFBP-3 levels, find an alternate method. (3) Immediately notify all parties of interest (e.g., laboratory staff, clinicians) of the possibility of erroneously elevated IGFBP-3 results for patient samples tested with these lots, and advise all parties that clinical decision making and patient safety may be impacted. (4) Review patient IGFBP-3 results for the lots listed above, and interpret them in the light of additional tests (e.g., IGF-1) and the patient's clinical status and history. Customers were also asked to share the recall information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. Complete and return the enclosed response form within 10 days. For any questions regarding this notification, customers were to contact the DSL Technical Support Center at 1-800-231-7970 option 4 in the United States, or contact your local Beckman Coulter Representative.

Recalling firm

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

Distribution

Distribution pattern: Nationwide in US and Canada

Timeline

Recall initiated: 2010-08-09
Posted by FDA: 2010-09-28
Terminated: 2012-08-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93769. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.