Device product
SporAmpule Biological Indicator Catalog Number SPS5-100
Z-1274-2018
Product summary
- Event
- Event 79374
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40,000 units
- Official record key
device-enforcement:Z-1274-2018
Official wording
Reason: The concentration of bromocresol purple in the recalled lots does not conform to specification.
Code information: Lots: SPS-696, SPS-697, SPS-698
Distribution pattern: United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, Jordan
Derived failure modes
-
Unknown
The concentration of bromocresol purple in the recalled lots does not conform to specification.