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Terminated

SporAmpule Biological Indicator Catalog Number SPS5-100

FDA Recall Z-1274-2018 · Posted None

Recalling FirmMesa Laboratories Bozeman Manufacturing Facility
Recall StatusTerminated
Product CodeFRC
Date Initiated2018-02-12
Date Terminated2018-07-03
Product Quantity40,000 units

Reason for Recall

The concentration of bromocresol purple in the recalled lots does not conform to specification.

Firm Action

Per the Recall Strategy, consignees have been requested to immediately discontinue use and discard according to site procedures.

Root Cause

Other

Distribution Pattern

United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, Jordan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K971432PROSPORERaven Biological Laboratories, Inc. · 1997-05-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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