SporAmpule Biological Indicator recall
SporAmpule Biological Indicator Catalog Number SPS5-100
Why was SporAmpule Biological Indicator recalled?
The concentration of bromocresol purple in the recalled lots does not conform to specification.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: SPS-696, SPS-697, SPS-698
- Product
- SporAmpule Biological Indicator Catalog Number SPS5-100
- Recalling firm
- Mesa Laboratories Bozeman Manufacturing Facility
- Quantity
- 40,000 units
- Distribution
- United States, Republic of Korea, Israel, Poland, France, China, Canada, Japan, Singapore, Hong Kong, Jordan
- Recall date
- April 4, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)