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Terminated

Direct Water feed Kit, Catalog#10373222

FDA Recall Z-1661-2015 · Posted 2015-05-23

Recalling FirmSiemens Medical Solutions Diagnostics
Recall StatusTerminated
Product CodeJJE
Date Initiated2015-03-05
Date Terminated2018-01-16
Product Quantity15 bottles

Reason for Recall

The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.

Firm Action

Siemens Healthcare Diagnostics sent an Urgent Device Correction Letter/Field Correction Effective Check Form dated 3/5/15 via FedEx to their affected customers.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970227IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZERDpc Cirrus · 1997-04-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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