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PrepStain GN 480 Disposable Kit Catalog/Model 490542 recallZ-1815-2012 · Tripath Imaging, Inc. · initiated Mar 22, 2012

Class III Terminated All recalls posted in June 2012

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 Tripath Imaging, 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

The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes

FDA root cause category: Component design/selection

What the company is doing

BD Diagnostics sent a "BD PrepMate Syringing Pipette" letter dated March 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The firm encouraged customers to refer to the Operator's Manual and inspect the centrifuge tubes to verify that the correct amount of sample has been transferred. Customers experiencing this issue were instructed to discard the pipettes and contact BD Diagnostic Technical Support for a replacement. Contact the firm at 1-877-822-7771 for questions regarding this notice.

Recall details

Recall number
Z-1815-2012
Recall class
Class III
Status
Terminated
Initiated by the company
Mar 22, 2012
Posted by the FDA
Jun 15, 2012
Recalling firm
Tripath Imaging, Inc.
Quantity
46,112,784 for all products in Recall Event
Product code
MKQ
FDA submissions
P970018
Distribution
Worldwide Distribution.

Product description

PrepStain GN 480 Disposable Kit Catalog/Model 490542 This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240)

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

This is a complete kit, per the firm's explanation, that contains the PrepStain Syringing Pipettes 240, the actual product being recalled. The affected lots are listed under those pipettes (PrepStain Syringing Pipettes 240), which are: 100901a, 100902f, 100902f, 100903d, 100908c, 100910c, 100914f, 100916d, 100921d, 100928c, 101005a, 101007d, 101008c, 101012c, 101013a, 101015c, 101020d, 101022c, 101027a, 101028c, 101029d, 101103b, 101105h, 101110f, 101111c, 101117p, 101118n,  101119c, 101130p, 101201o, 101207o, 101208p, 101210c, 101213n, 101214b, 101214c,  101217b, 101220q, 101221g, 110104b, 110106a, 110107c, 110110d, 110112n, 110118b,  110128i, 110203i, 110210r

Other devices under the same FDA submission

13 devices cleared under P970018 — 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 61737).

Sources and updates

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