Beckman Coulter Inc.: Active I-PTH ELISA, Part Number: DSL-10-8000 The DSL-10-80000 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.

Recall number

Z-0584-2011

Recalling firm

Beckman Coulter Inc.

Product

Active I-PTH ELISA, Part Number: DSL-10-8000 The DSL-10-80000 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.

Status

Terminated

Initiated

2010-04-22

Posted

2010-12-09

Terminated

2012-05-07

Reason

The recall was initiated because Beckman Coulter has confirmed that the stated stability of the DSL-10-8000 I-PTH ELISA and DSL-8000 I-PTH IRMA assays may not be achieved for the lot numbers affected by the recall. The affected I-PTH ELISA and the I-PTH IRMA kit lots may produce falsely elevated patient results. Internal stability testing showed an average 16% elevation for I-PTH ELISA lot 99

Root cause

Pending

Action

Beckman Coulter sent an Urgent Product Corrective Action Letter to their consignees dated June 18, 2010. The letter identified the product, the problem, and the action to be taken. Consignees were instructed to: (1) Discontinue use of all materials provided with I-PTH ELISA kit lot number 992751 and I-PTH IRMA lot numbers 090013, 090121, and 090372. (2) Review historical external quality control results to ensure the assay performance of these lots was within laboratory specifications. Retesting may be necessary if their laboratory uses only the Control materials provided with the I-PTH ELISA and IRMA kits. (3) Abnormal 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 number 992751 and I-PTH IRMA lot numbers 090013, 090121, and 090372 will no longer be shipped. Due to the calibrator instability recently encountered with DSL-10-8000 I-PTH ELISA and DSL-8000 I-PTH IRMA assays, Beckman Coulter has decided to immediately discontinue these two part numbers. Consignees were asked to share this information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Complete and return the enclosed response form within 10 days so Beckman Coulter can be assured that they received this important notification. If they have any unused product the were asked to contact the numbers listed below: (1) In the United States, contact Customer Service at 1-800-526-382.1 (2) Outside of the United States, consignees were asked to contact their local Beckman Coulter Representative Consignees were told to contact DSL Technical Support Center at 1-800-231-7970 in the United States, or their local Beckman Coulter Representative with any questions. For questions regarding this recall call (714) 961-3634.

Quantity

3 kits

Distribution

Worldwide Distribution - USA including MD, NY, GA, NJ, CA, MI, TX, PA, IA, and IN. Internationally to Austria, Brazil, China, Colombia, Czech Republic, France, Germany, Hong Kong, India, Japan, Mexico, and the Russian Federation

Lot, serial or model codes

Lot Numbers: 992751

510(k) numbers

["K952199"]

PMA numbers

not on file

Product code

CEW

Firm FEI

2050012

Firm city

Brea

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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