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Recall Observatory FDA recall evidence

Device product

Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Z-1362-2019

April 09, 2019

Class III

Product summary

Firm
Abbott Laboratories
Event
Event 82590
Status
Terminated
Classification
Class III
Quantity
1 unit
Official record key
device-enforcement:Z-1362-2019

Official wording

Reason: Devices were delivered without the required dry ice.

Code information: LN 5P78-10; Lot 18004181

Distribution pattern: Distribution to Latvia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Devices were delivered without the required dry ice.