AIA Analyzer Pipette Tips used on Tosoh AIA-2000 — Class II medical device recall Z-1830-2013
Terminated recall by Tosoh Smd Inc, reported 2013-08-07, distributed in AK, AL, AR, AZ, CA, CO, CT, DE…. Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which wa
| Recall number | Z-1830-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tosoh Smd Inc, Grove City, OH, United States |
| Recall initiated | 2013-05-15 |
| Classified | 2013-07-30 |
| Reported by FDA | 2013-08-07 |
| Terminated | 2013-11-27 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY |
| Countries outside the US | CA, CL, JP, MX, UY |
| Quantity | 11,309 bags |
Product
AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag AIA-Analyzer Tips are disposable pipette tips packaged in bulk quantities and used on Tosoh Bioscience AIA Analyzers for lab analysis of various immunoassays.
Reason for recall
Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which was causing error messages on the analyzers.
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-1830-2013. 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.