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CELL-DYN Sheer Valve Assembly Driver recallZ-2020-2011 · Abbott Laboratories · initiated Mar 15, 2011

Terminated All recalls posted in April 2011

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 Abbott Laboratories 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

The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.

FDA root cause category: Pending

What the company is doing

Product Correction letters were sent on March 15, 2011. via Federal Express. The letter identified the affected product, explained the problem, the patient impact and the necessary action that were to be taken. Customers were to review the letter and inform their Laboratory Manager of the pending action.; complete and return the Customer Reply Form; and save a copy of the letter for their records. If there were any questions, customers were to contact Customer Support at 1-877-4ABBOTT or their local hematology customer support representative for customers outside of the US.

Recall details

Recall number
Z-2020-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Mar 15, 2011
Posted by the FDA
Apr 29, 2011
Recalling firm
Abbott Laboratories
Quantity
174 total units, all varieties
Product code
GKZ
FDA submissions
K991605
Distribution
Worldwide Distribution -- AZ, CA, FL, IA, ID, IN, MA, MI, MN, MS, ND, NY, OK, OR, SC, SD, TX, WI, WY and Germany, Singapore, Mexico, China, South Korea, Argentina, Japan, Brazil, Canada, Australia, and Chile.

Product description

CELL-DYN Sheer Valve Assembly Driver Abbott Diagnostics Division, Santa Clara, CA 05054

Code information (models, lots, serial numbers)

List Number 8921204902:  Date Code 20-Jan-2011 Pallet ID 48312339; Date Code 08-Feb-2011 Pallett ID 95795162.  List Number 8921167602: Date Code 13-Dec-2010 Pallet ID 80671954; Date Code 15-Dec-2010 Pallet ID 32777397; Date Code 16-Dec-2010 Pallet ID 46425128; Date Code 18-Jan-2011 Pallet ID 42387574; and Date Code 20-Jan-2011 Pallet ID 35758457.

Other devices under the same FDA submission

3 devices cleared under K991605 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 58188).

Sources and updates

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