Device recall

Z-0635-2013: Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry…

FDA device recall · Class III · Siemens Healthcare Diagnostics Inc

Key facts

Recall number (Z-number) Z-0635-2013
Recall event 63809
Product Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek-Stix Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX positive and negative control strips provide defined results…
Product code JJW
Recalling firm Siemens Healthcare Diagnostics Inc
Recall class Class III
Status Terminated
Termination date Nov 6, 2014
510(k) numbers K943780
FEI number 3002637618

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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