Tryptic Soy Agar — Class II medical device recall Z-1093-2017
Terminated recall by Acumedia Manufacturers, Inc., reported 2017-02-01, distributed in AR, CA, CT, FL, GA, ID, IL, IN…. light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. While there is
| Recall number | Z-1093-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acumedia Manufacturers, Inc., Lansing, MI, United States |
| Recall initiated | 2016-04-22 |
| Classified | 2017-01-25 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2018-09-19 |
| Distributed | AR, CA, CT, FL, GA, ID, IL, IN, MD, ME, MI, NC, ND, NY, OH, OR, TN, TX, UT, VA, WI |
| Countries outside the US | AU, BR, CA, CL, CO, GB, ID, IL, MX, TW |
| Quantity | 482 |
| Reason classes | specification failure |
| Lot numbers | 108-1, 108166A, 108166B, 108166C, 7100B, 7100C, 7100CAR, 7100D |
Product
Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes
Reason for recall
light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. While there is no change in growth performance of this medium, the formation of particulate matter may be misinterpreted as growth in poured plates thereby leading to inaccurate counts.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1093-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.