The Recall Desk
LowFDA (Devices)·Z-1928-2019·Announced 2019-07-10

Roche cobas p 701 Post-Analytical Units Recalled for Loose Flap

Roche Diagnostics is recalling nine cobas p 701 post-analytical units because the tray input flap may become loose and detach.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard is a mechanical defect (loose flap) with no reported injuries.

Plain-English summary

Roche Diagnostics Corporation is recalling nine cobas p 701 post-analytical units, Part Number 05349966001. These devices are used for diagnostic sample storage and retrieval. The recall involves units with serial numbers 1001 through 1037, and 502.

The recall is due to a potential defect where the tray input flap on the post-analytical units may become loose and potentially detach from the instrument. No injuries or illnesses have been reported in connection with this recall.

The affected units were distributed nationwide in the states of Alabama, California, Florida, Iowa, Illinois, Kentucky, Maryland, Oregon, and Pennsylvania. Users should contact Roche Diagnostics Corporation for further instructions on how to proceed.

The recalled product

Product
cobas p 701 post-analytical units, Part Number 05349966001. For diagnostic sample storage and retrieval.
Manufacturer
Roche Diagnostics Corporation
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
9

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Serial Numbers - 1001 through 1037
  • and 502

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Roche Diagnostics Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Roche Diagnostics Corporation

See all →

Same hazard · mechanical defect

See all →