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Synchron recallZ-1752-2020 · Beckman Coulter Inc. · initiated Sep 4, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Beckman Coulter Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.

FDA root cause category: Material/Component Contamination

What the company is doing

An Urgent Medical Device Recall Letter was sent to customers via either U.S. postal service or email beginning on 9-4-2019. The letter informs customers that studies indicate that cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP) and Opiate 2000 ng (OP2) Instructions For Use (IFU). This letter included the Instructions for Use (IFU) claims versus study results for each product. Customers were informed of which compounds (at specific concentrations or ranges) may result in false positive or false negative test results. The letter indicated that Laboratories should be aware of these findings but that retrospective review of results is not required. Customers were informed that resolution of this issue was handled by revising the Opiate 300 ng (OP) Reagent IFU and the Opiate 2000 ng (OP2) Reagent IFU to update the Cross Reactivity sections. Customers were also requested to provide a copy of the letter to any other laboratory to which they may have forwarded affected product. Customers were requested to acknowledge receipt of the recall notification letter by responding to Beckman Coulter within 10 days either electronically, if the letter was received via email, or manually by completing and return the enclosed Response Form. Customers were instructed to contact the Beckman Coulter Customer Support Center through their website at http://www.beckmancoulter.com/customersupport/support; or by phone at 1-800-854-3633 in the United States and Canada with any questions. Customers outside of the U.S. and Canada were instructed to contact their local Beckman Coulter Representative.

Recall details

Recall number
Z-1752-2020
Status
Terminated
Initiated by the company
Sep 4, 2019
Posted by the FDA
Apr 20, 2020
Recalling firm
Beckman Coulter Inc.
Quantity
7,951 units
Product code
DJG
FDA submissions
K031002
Distribution
Distributed throughout the United States and to Puerto Rico. States include: CA, NC, OR, MI, GE, AL, SC, TX, NJ, IA, MS, IN, MA, NC, OH, AZ, LA, MA, NY, PA, KY, WV, MI, WA, CO, IL, VA, FL, KS, MD, ID, DE, NV, OK, AR, HI, WI, NY.

Product description

Opiate 300 Ng Reagent (OP 1 X 250) for use in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems OP 300 Urine Calibrators, Catalogue No.475024. The OP assay provides a rapid screening procedure for determining the presence of OP and its metabolites in urine.

Code information (models, lots, serial numbers)

Catalog Number 475024; UDI:15099590222970 ; Lot Numbers: M904130 and older including M802097, M803045, M804024, M805123, M806080, M808069, M809218, M810293, M901044, M902086, and M903175.   .

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 85289).

Sources and updates

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