Home › Alere Scarborough, Inc. › ISOLATOR™ 1.5 mL Microbial Tubes
ISOLATOR™ 1.5 mL Microbial Tubes
Alere Scarborough, Inc. · Model 50C5 · UDI-DI 10811877010958
1
510(k) clearances
179
Adverse events
3
Recalls
43
Facilities
Description
The ISOLATOR 1.5 mL microbial tube is intended for use in the collection of small volume pediatric blood samples to be used in the isolation of microorganisms.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-08 | Hologic, Inc. | Three lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty, underfilled, or overfilled with extract |
| 2020-07-14 | Thomas Scientific | The firm is replacing all tubes that were manufactured and distributed prior to Enforcement Discretion Approval. |
| 2009-05-07 | Remel, Inc | Incorrect expiration date on the product |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.