5 mL Reaction Vessels — Class II medical device recall Z-2169-2014
Terminated recall by Abbott Molecular, reported 2014-08-20, distributed nationwide. Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 56944001, 57026001,
| Recall number | Z-2169-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Molecular, Des Plaines, IL, United States |
| Recall initiated | 2014-06-19 |
| Classified | 2014-08-08 |
| Reported by FDA | 2014-08-20 |
| Terminated | 2016-02-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CH, CN, DE, ES, FI, FR, GB, ID, IE, IL, IN, IT, KE, KR, MY, NL, NO, NZ, PH, PK, PL, PT, RU, SE, SG, TH, TR, TW, UA, VN, ZA |
| Quantity | 1,688,000 reaction |
| Serial numbers | 56944001, 57026001, 57059001, 57673001 |
Product
5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments. The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments.
Reason for recall
Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 56944001, 57026001, 57059001, and 57673001 (original vendor lot 2198077) may have an insufficient rim. An RV with an insufficient rim may not be held securely in the 1 mL Subsystem Carrier. This may cause the RV to be seated incorrectly in the carrier or drop through it.
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-2169-2014. 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.