Z-0107-2011

Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000 The DSL-10-8000 ACTIVE I-PTH...

Name: Z-0107-2011 Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000 The DSL-10-8000 ACTIVE I-PTH...
Creator: Beckman Coulter Inc.
Published: 2010-03-04
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-03-04 / Terminated

FDA source

Beckman Coulter Inc. began a recall of Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000 The DSL-10-8000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit... on 2010-03-04. The reason FDA records is "The recall was initiated after Beckman Coulter confirmed that the stated stability of the DSL-10-8000 I-PTH ELISA assay may not be achieved for lot numbers: 891198, 990980 and 991448. The kit lot numbers listed above...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0107-2011
Status: Terminated
Initiated: 2010-03-04
Posted: 2010-10-20
Terminated: 2012-04-27
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Active I-PTH Enzyme-Linked Immunosorbent Assay(ELISA), Part Number: DSL-10-8000 The DSL-10-8000 ACTIVE I-PTH Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of I-PTH in serum or plasma. This assay is intended for in vitro diagnostic use as an aid in the diagnosis of hyperparathyroidism
Product code: CEW Radioimmunoassay, Parathyroid Hormone
Reason for recall: The recall was initiated after Beckman Coulter confirmed that the stated stability of the DSL-10-8000 I-PTH ELISA assay may not be achieved for lot numbers: 891198, 990980 and 991448. The kit lot numbers listed above passed the stability testing performed at 6 months, but failed the testing performed at 12 months. Therefore the affected I-PTH ELISA kit lots may produce falsely elevated patient r
FDA root cause: Other
Action: Beckman Coulter sent an URGENT: PRODUCT CORRECTIVE ACTION letter dated March 17, 2010 with attached Customer Response form to all customers who received Active I-PTH ELISA kits with the affected lot numbers. The letter identified the product, the problem, and the actions to be taken. Customers were instructed to: (1) Discontinue use of all materials provided with I-PTH ELISA kit lot numbers 891198, 990980 and 991448; (2) Review historical external quality control results to ensure the assay performance of these lots was within laboratory specifications. Retesting may be necessary if your laboratory uses only the control materials provided with the I-PTH ELISA kit; (3) Abnormally elevated patient results that are obtained with these lot numbers and that are inconsistent with the patient's clinical status should be reviewed in the context of other clinical diagnostic tests; (4) I-PTH ELISA kit lot numbers 891198, 990980 and 991448 will no longer be shipped. Alternate lots will be provided for current and future replenishment orders or requests. in addition customers were instructed to share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. Complete and return the enclosed response form within 10 days. For questions regarding this recall contact (800) 231-7970.
Quantity in commerce: 70 kits
Distribution: Nationwide Distribution including the states of CA, CT, IA, IL, MI, NY, SC, and TX
Product codes and lots: Lot Numbers: 891198, 990980, 991448

Product code CEW

K952199Class IIActive Intact Pth ElisaDiagnostic Systems Laboratories, Inc. / cleared 1995-07-17

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)