Z-2607-2010

IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part Number: DSL-6600 usage: The DSL6600 IGFBP-3...

Name: Z-2607-2010 IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part Number: DSL-6600 usage: The DSL6600 IGFBP-3...
Creator: Beckman Coulter Inc.
Published: 2010-08-09
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-08-09 / Terminated

FDA source

Beckman Coulter Inc. began a recall of IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part Number: DSL-6600 usage: The DSL6600 IGFBP-3 immunoradiometric assay (IRMA) kit provides materials for the... on 2010-08-09. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2607-2010
Status: Terminated
Initiated: 2010-08-09
Posted: 2010-09-28
Terminated: 2012-08-13
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: CFL Radioimmunoassay, Human Growth Hormone
Reason for recall: 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
FDA root cause: Pending
Action: 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.
Quantity in commerce: 63
Distribution: Nationwide in US and Canada
Product codes and lots: Lot Numbers: 991017, 991225, 991384, 991694, 991938, 992171, 992372, 992703, 100115A, 100205A, 100205B, 100226A, 100319A, 100409A, 100409B, 100430A and 100521A

Product code CFL

K950228Class IDsl Active Igfbp-3 Irma (Dsl 6600)Diagnostic Systems Laboratories, Inc. / cleared 1995-02-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)